Clinical Research
Comparison of Titanium-Nitride-Oxide–Coated Stents With Zotarolimus-Eluting Stents for Coronary Revascularization: A Randomized Controlled Trial

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Objectives

This study sought to compare the efficacy of passive stent coating with titanium-nitride-oxide (TiNO) with drug-eluting stents releasing zotarolimus (ZES) (Endeavor, Medtronic, Minneapolis, Minnesota).

Background

Stent coating with TiNO has been shown to reduce restenosis compared with bare-metal stents in experimental and clinical studies.

Methods

In an assessor-blind noninferiority study, 302 patients undergoing percutaneous coronary intervention were randomized to treatment with TiNO or ZES. The primary endpoint was in-stent late loss at 6 to 8 months, and analysis was by intention to treat.

Results

Both groups were well balanced with respect to baseline clinical and angiographic characteristics. The TiNO group failed to reach the pre-specified noninferiority margin for the primary endpoint (in-stent late loss: 0.64 ± 0.61 mm vs. 0.47 ± 0.48 mm, difference: 0.16, upper 1-sided 95% confidence interval [CI]: 0.26; pnoninferiority = 0.54), and subsequent superiority testing was in favor of ZES (psuperiority = 0.02). In-segment binary restenosis was lower with ZES (11.1%) than with TiNO (20.5%; psuperiority = 0.04). A stratified analysis of the primary endpoint found particularly pronounced differences between stents among diabetic versus nondiabetic patients (0.90 ± 0.69 mm vs. 0.39 ± 0.38 mm; pinteraction = 0.04). Clinical outcomes showed a similar rate of death (0.7% vs. 0.7%; p = 1.00), myocardial infarction (5.3% vs. 6.7%; p = 0.60), and major adverse cardiac events (21.1% vs. 18.0%, hazard ratio: 1.19, 95% CI: 0.71 to 2.00; p = 0.50) at 1 year. There were no differences in rates of definite or probable stent thrombosis (0.7% vs. 0%; p = 0.51) at 1 year.

Conclusions

Compared with TiNO, ZES was superior with regard to late loss and binary restenosis. The concept of passive stent coating with TiNO remains inferior to drug-eluting stent technology in reducing restenosis. ([TIDE] Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent: NCT00492908)

Key Words

passive stent coating
titanium-nitride-oxide–coated stent(s)
zotarolimus-eluting stent(s)

Abbreviations and Acronyms

CI
confidence interval
CK
creatine kinase
DES
drug-eluting stent(s)
IQR
interquartile range
TiNO
titanium-nitride-oxide
TLR
target lesion revascularization
ZES
zotarolimus-eluting stent(s)

Cited by (0)

Supported by the Inselspital Foundation. Dr. Jüni is an unpaid member of steering groups and planning committees of cardiovascular trials funded by Abbott Vascular, Biosensors, Cordis, Medtronic, and St. Jude Medical. Dr. Windecker received research grants from Abbott, Cordis, Medtronic, Biosensors, and Biotronik. All other authors have reported that they have no relationships to disclose. Drs. Pilgrim and Räber contributed equally to this work. Sotirios Tsimikas, MD, served as Guest Editor for this paper, and this paper was accepted before he became a new Associate Editor.